The Clinical Study on the Management of Sthula Madhumeha by Herbal Drugs

Cloud Publications International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 2015, Volume 4, Issue 1, pp. 266-274, Article ID Med-247 ISSN: 2320 0251 Research Article Open Access The Clinical Study on the Management of Sthula Madhumeha by Herbal Drugs Chawre Sushil Vilas 1, Sonawne D.G. 2, Kabra P.R. 3 and Bombarde D.T. 4 1 Department of Kayachikitsa, Govt. Ayurved College, Nagpur, Maharashtra, India 2 Department of Kayachikitsa, Vimalabai Ayurved College, Wandri, Chandrapur, Maharashtra, India 3 Department of Kayachikitsa, Govt. Ayurved College, Nagpur, Maharashtra, India 4 Department of Panchkarma, Govt. Ayurved College, Nagpur, Maharashtra, India Publication Date: 28 August 2015 Article Link: http://medical.cloud-journals.com/index.php/ijaayush/article/view/med-247 Copyright 2015 Chawre Sushil Vilas, Sonawne D.G., Kabra P.R. and Bombarde D.T. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Ayurveda originated along with nature for the management of health and diseases of the human beings. Ayurveda described Dincharya and Rutucharya to maintain health, ultimately first aim of Ayurveda. But at present due to several causes people does, not follow that type of lifestyle, in proper way which leads to several life threatening problems, IHD, Cardiac problems, Kidney diseases, HTN and other. Sthula Madhumeha (Obesity induced DM) is one of them. Now days, proportion of Sthula Madhumeha (Obesity induced DM) increases very rapidly with various complications which is very hazardous to human creatures and leading to death in many situations. But no satisfactory management up till now is available for Sthula Madhumeha (Obesity induced DM) though several research works carried out. Keeping, this view into mind, Apatarpana- Chikitsa is given to the patients under clinical study. For that Kadar (acacia sumo) Sara, Khadir (Acacia catechu) Churna and Pugphala (Acacia Arabica) churna were taken for research work, which was described by Chakradatta. Clinical study entitled as The clinical study on the management of Sthula Madhumeha by herbal drugs. The enrollment number of the study is NU/A5/9210 on 17/03/2005. The study was done in Government Ayurved College and hospital as dissertations in department of Kayachikitsa. Keywords Sthula Madhumeha; Kadar, Khadir; Pugphala; Apatarpana 1. Introduction Ayurveda originated along with nature for the management of health and diseases of the human beings. Ayurveda described Dincharya and Rutucharya to maintain health, ultimately first aim of Ayurveda. But at present due to several causes people does, not follow that type of lifestyle, in proper way which leads to several life threatening problems, IHD, Cardiac problems Kidney diseases, HTN and other, Sthula Madhumeha (~Obesity induced DM) is one of them. Diabetes mellitus is a syndrome characterized by chronic hyperglycemia that is due to relative insulin deficiency or resistance or both [1]. The number of people with DM increase with the age of the population, ranging from an incidence of 1.5% in individuals from 20 to 39 years to 20% of individuals

>75 years. The incidence of DM is similar in men and women throughout age ranges but is slightly greater in men > 60 years [2]. Now days, proportion of Sthula Madhumeha (~Obesity induced DM) increases very rapidly with various complications which is very hazardous to human creatures and leading to death in many situations. But no satisfactory management up till now is available for Sthula Madhumeha (~Obesity induced DM) though several research works carried out. Keeping, this view into mind, Apatarpana- Chikitsa [3] is given to the patients under clinical study. For that Kadar (acacia sumo) Sara, Khadir (Acacia catechu) Churna and Pugphala (Acacia Arabica) churna were taken for research work, which was described by Chakradatta [4]. Clinical study entitled as The clinical study on the management of Sthula Madhumeha by herbal drugs. The study was done in Government Ayurved hospital, as dissertations from 2005 to 2008. 1.1. Aims and Objectives Aims and objectives of this study were pinpointed as follows. a) To evaluate the Dosha-Dushya Sammurchhana of Sthula Madhumeha (~Obesity induced DM) with relation to Samprapti. b) To evaluate the effect of Kadaradi herbal compound in Sthula Madhumeha (~Obesity induced DM). c) To compare the effect of Kadaradi herbal compound with Metformin. d) To evaluate the effect of drug on Blood sugar level and Lipid profile. e) To evaluate the effect of drug on Physical Characters such as weight of body, Body mass index, circumference of chest, abdomen, waist, hip and hip to waist ratio. f) To evaluate the effect of drug on urine and urine sugar. g) To review the past and present literary work of Madhumeha. 2. Materials and Methods 60 patients suffering from Sthula Madhumeha (~Obesity induced DM) were randomly selected irrespectively to age, sex, caste, religion, socio economical and educational status. All the patients were examined on the basis of special case paper for the dissertation. Necessary investigations were performed to rule out any other pathology. In treated group Kadaradi compound were given to the patients while Metformin given to control group patients of Sthula Madhumeha. 2.1. Criteria of Diagnosis a) The patients were diagnosed on the basis of signs and symptoms of Sthula Madhumeha (~Obesity induced DM), which are described in Ayurvedic text as well as the symptoms like Mukha Madhurya (~sweetness of mouth), Supti (~Numbness), Daha (~burning sensation), Avil Mutrata (~ turbid urine), Prabhuta Mutrata (~ frequent micturition) [5]. b) Necessary investigations were carried out like BSL Fasting- Post meal, Lipid profile and BMI for confirmation of diagnosis and in doubtful cases to rule out other systemic disease. 2.2. Criteria of Selection The patients complaining signs and symptoms which are described earlier and fulfilling the criteria of diagnosis were selected for study. International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 267

2.3. Criteria of Rejection The patients who had post meal blood sugar level more than 350 mg/dl and Body mass index less than 25 and who bears fatal complication were also rejected for clinical study. 2.4. Groups of Management All the 60 patients, diagnosed with the help of criteria of diagnosis were randomly categorized into two groups. 30 patients in the treated group were given to capsules of Kadaradi herbal drugs orally along with Luke warm water before meal twice in a day for 6 weeks, while in control group 500 mg Metformin BD given to the patients before meal [6]. 2.5. Criteria of Assessment Patients assessed after complete therapy in connexion to following points. a) Effect of Kadaradi compound drugs and Metformin on symptoms and signs of patients of Sthula Madhumeha (~Obesity induced DM). b) Effect of therapy on quantity and specific gravity of Urine and Urine Sugar. c) Effect of therapy on fasting and post meal blood sugar level. d) Effect of therapy on cholesterol level and lipid profiles. e) Effect of therapy on body mass index, abdominal circumference, waist circumference, hip waist ratio. 2.6. Effect on Symptoms Score Effect on symptoms of Sthula Madhumeha (~Obesity induced DM) evaluated with the help of scoring system. This scoring system was described by Thatere A. (2004) in his P.G. Thesis. The general symptoms score system adopted for the statistical analysis was as follows a) Two marks were allotted each symptom present before the treatment. b) One mark was allotted to each of the symptom, which reduced remarkably often the treatment. c) Complete relief in the symptoms was taken zero mark. d) No improvement in symptoms after completion of therapy considered as two marks. The same symptoms score used for Dosha and Dhatu dusti lakshanas. The important parameters used in this study were evaluated as follows. [A]. Weight Weight measure of the patient before treatment every follow-up change in weight noted then the after therapy weight measure three times successively and calculated. International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 268

[B]. Body-Mass index [7] Body mass index calculated before and after by following formulae. BMI = Weight in kg / (Height in meter) [2] [C]. Circumferences Hip, Waist, Abdomen, Chest, Hip-Waist Ratio Measurements of these parameters are as same as weight measurement method. Hip measurement was taken at the level of greater trochanter and waist measurement was taken from anterior-superior iliac spine, then Hip waist ratio calculated for Sthulata (~obesity) of patient. In same manner chest measurement was taken from at the nipple level and abdomen measured at navicular region. [D]. Blood Pressure Blood pressure measured before and after treatment. It is also measured in every follow-up by auscultatory method with sphygmomanometer. [E]. Urine Examination (a) Urine Quantity The patients, twenty four hour urine collection measure in liters; before and after treatment. In between this period 24 hours urine collection from 8.00 am to 8.00 am measured at every successive follow up. Finally mean of urine quantity calculated for accuracy. (b) Specific Gravity Specific gravity measured with urinometer before and after treatment. (c) Urine Sugar Urine Sugar investigated as post meal before and after therapy by strip method. [F]. Laboratory Investigations Maintain record of all laboratory investigation such as Hemoglobin %, Total leucocyte count, Differential leucocyte count, erythrocyte sedimentation rate, fasting blood sugar, post prandial blood sugar, lipid profile. The changes in investigations were noted and maintain the record. The overall effect of this therapy in both the groups was assumed according to synopsis of this study previously submitted to university for adjudication. Total effect of therapy was assessed in terms of cured, markedly cure, improved, unchanged and LAMA i.e. left against medical advice. International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 269

a) Cured Complete relief in the signs and symptoms along with certain physical and laboratory parameter and maintained the same condition for about long duration without medicine was considered as cured. b) Markedly Improved The signs and symptoms of Sthula Madhumeha (~Obesity induced DM) relived in between 50% to 75% along with improved physical and biochemical change was considered as markedly improve. c) Improved Signs and symptoms of Sthula Madhumeha (~Obesity induced DM) relived between, 25% to 50% was considered as improved. d) Unchanged The signs and symptoms of Sthula Madhumeha (~Obesity induced DM) relieved below 25% and proved by laboratorial investigations was considered in unchanged category. e) LAMA The patient of Sthula Madhumeha (~Obesity induced DM) who left the treatment in between without consultation or against medical advice due to some unavoidable circumstances was included in this group. They termed as leave against Medical advice. 3. Observation and Results Table 1: Showing Incidence of Clinical Features in 60 Patients of Sthula Madhumeha S.N. Clinical Features Total No. of Patients Percentage of 1 Mukha Madhurya(~sweetness in mouth) 56 93.33% 2 Supti(~numbness) 49 81.67% 3 Daha(~burning sensation) 55 91.67% 4 Trishnadhikya(~polydipsia) 57 95% 5 Alasya(~laziness) 57 95% 6 Maladhikya 42 70% 7 Nidradhikya(~excessive sleep) 58 96.67% 8 Tandra 51 85% 9 Mutradhikya(polyuria) 60 100% 10 Avil-mutrata 60 100% 11 Kshudhadhikya(polypepsia) 60 100% 12 Medadhikya(excessive fat) 59 96.67% 13 Anutsaha 50 83.33% 14 Sakashta-Maithuna(~difficulty in intercourse) 34 56.67% 15 Durbalata(~weakness) 51 85% 16 Durgandhirharir(~bad odour) 50 53.33% 17 Svedadhikya(~excessive sweat) 57 95% International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 270

Table 2: Showing Effect of Herbal Drug on Symptom Score in 60 Patients of Sthula Madhumeha S.N. Symptom Groups Symptoms Score Percentage B.T. A.T. Diff. 1 Mukha Madhurya(~sweetness in mouth) Treated Group 56 14 42 75% Supti(~numbness) Controled Group 39 13 26 66.66% 2 Daha(~burning sensation) Treated Group 54 09 45 83.33% Trishnadhikya(~polydipsia) Controled Group 35 10 25 71.42% 3 Alasya(~laziness) Treated Group 34 10 44 81.48% Maladhikya Controled Group 40 10 30 75% 4 Nidradhikya(~excessive sleep) Treated Group 58 20 38 65.51% Tandra Controled Group 46 19 27 58.69% 5 Mutradhikya(polyuria) Treated Group 51 11 40 78.43% Avil-mutrata Controled Group 44 17 27 61.36% 6 Kshudhadhikya(polypepsia) Treated Group 30 08 22 73.33% Medadhikya(excessive fat) Controled Group 33 13 20 60.00% 7 Anutsaha Treated Group 48 08 40 83.33% Sakashta-Maithuna(~difficulty in intercourse) Controled Group 40 12 28 70% 8 Durbalata(~weakness) Treated Group 47 09 38 80.85% Durgandhirharir(~bad odour) Controled Group 39 11 28 71.79% 9 Svedadhikya(~excessive sweat) Treated Group 59 20 39 66.10% Mukha Madhurya(~sweetness in mouth) Controled Group 41 12 29 70.73% 10 Supti(~numbness) Treated Group 60 16 44 73.33% Daha(~burning sensation) Controled Group 44 15 29 65.90% 11 Trishnadhikya(~polydipsia) Treated Group 55 17 38 69.09% Alasya(~laziness) Controled Group 41 10 31 75.60% 12 Maladhikya Treated Group 54 13 41 75.92% Nidradhikya(~excessive sleep) Controled Group 43 13 30 69.76% 13 Tandra Treated Group 47 12 35 74.46% Mutradhikya(polyuria) Controled Group 32 06 26 81.25% 14 Avil-mutrata Treated Group 05 02 03 60% Kshudhadhikya(polypepsia) Controled Group 07 05 02 71.14% 15 Medadhikya(excessive fat) Treated Group 51 15 36 70.58% Anutsaha Controled Group 32 12 20 62.5% 16 Sakashta-Maithuna(~difficulty in intercourse) Durbalata(~weakness) Treated Group 51 12 39 76.49% Controled Group 33 09 24 72.72% 17 Durgandhirharir(~bad odour) Treated Group 55 16 39 70.90% Controled Group 36 09 27 75% Table 3: Showing Effect of Therapy on Certain Parameters of 60 Patients of Sthula Madhumeha S.N Parameters Group Mean + SD Diff. of Mean + SD SEd T p BT AT 1. Weight in Kg. T.C. 77.17 + 14.67 73.7+14.66 3.47+1.7 0.31 11.19 <0.001 C.G. 69.2+10.91 66.4+10.50 2.8+0.96 0.176 5.45 <0.001 2. B.M.I. in Kg/m2 T.C. 28.17+3.15 26.70+3.05 1.47+1.11 0.20 7.15 <0.001 C.G. 28.744+2.54 27.54+2.45 1.204+0.418 0.076 15.76 <0.001 3. Hip Circumference in T.C. 99.3+6.44 96.97+5.94 2.33+1.30 0.24 9.71 <0.001 cm C.G. 97.17+1.95 95.7+2.12 1.47+0.504 0.92 15.57 <0.001 4. Waist. Circumference T.C. 96.33+6.01 95.56+5.99 0.77+0.95 0.173 10.57 <0.001 in Cm C.G. 96.1+1.94 95.06+2.21 1.04+0.96 0.175 5.88 <0.001 5. Abdominal T.C. 96.7+7.071 95.33+6.87 1.33+0.844 0.154 8.63 <0.001 Circumference in Cm C.G. 95.03+2.89 94.43+2.47 0.6+0.72 0.132 4.54 <0.001 6. Chest Circumference T.C. 87.23+5.34 86.97+5.03 0.26+0.45 0.082 3.17 <0.001 International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 271

in Cm C.G. 86.43+2.76 86.17+2.72 0.26+0.149 0.082 3.24 <0.001 7. Hip to waist ratio T.C. 0.019+0.018 1.01+0.016 0.09+0.014 0.0026 5 <0.001 C.G. 1.010+0.0098 1.006+0.0084 0.004+000766 0.00141 5.43 <0.001 8. Systolic B.P. in mm/hg. T.C. 143.33+10.93 134.67+12.24 8.66+6.83 1.25 7.52 <0.001 C.G. 140+8.70 133+7.02 7+6.51 1.190 5.88 <0.001 9. Diastolic B.P. mm/hg T.C. 87.67+10.40 80.66+8.27 7.01+7.59 1.39 6.47 <0.001 C.G. 92.67+6.91 83+7.94 9.67+8.50 1.55 6.23 <0.001 Table 4: Showing Effect of Therapy on Lipid Profiles of 60 Patients of Sthula Madhumeha by Paired t Test S.N Parameters Group Mean + SD Diff. of Mean + SEd t P BT AT SD 1. Total Cholesterol in Treated 187.5 + 49.77 158.23+41.05 29.27+38.51 7.040 4.78 <0.001 Units Mg/dl Control 195.10+64.16 156.09+31.03 39.01+61.14 11.17 4.53 <0.001 2. High density Treated 46.44+12 43.80+12.24 2.64+18.04 3.298 0.998 >0.1 Lipoprotein in mg/dl Control 40.75+8.97 41.14+9.57-0.39+12.75 2.33 0.33 >0.1 3. Low density Treated 118.83+51.55 88.47+31.06 30.36+40.17 7.34 5.21 <0.001 Lipoproteins Control 121.6+60.44 94.95+29.44 26.65+54.31 9.92 4.39 <0.001 4. Serum Treated 194.4+252.42 150.86+141.66 43.54+153.87 28.13 2.32 <0.02 Triglycerides mg/dl Control 148.87+67.37 131.30+50.54 17.57+53.81 9.83 3.82 <0.001 Table 5: Showing Effect of Therapy on Urine Examination of 60 Patients of Sthula Madhumeha, by Paired t Test S.N Parameters Group Mean + SD Diff. of Mean + SEd t p BT AT SD 1. Quantity in Ltrs Treated 2.13 + 0.307 1.65+0.247 0.48+0.224 0.0409 11.49 <0.001 Control 2.03+0.215 16.3+0.269 0.4+0.237 0.0434 9.21 <0.001 2. Specific gravity Treated 1.026+ 0.004412 1.02+0.0331 0.001+ 0.00322 0.00588 11.105 <0.001 Control 1.019+0.002395 1.015+ 0.00188 0.004+ 0.00237 0.000433 9.37 <0.001 Table 6: Showing Effect of Therapy on Blood Sugar Level In 60 Patients of Sthula Madhumeha, by Paired t Test S.N Blood Sugar Level Group Mean + SD Diff. of Mean SEd t P BT AT + SD 1. Fasting blood sugar Treated 168.5 + 20.78 131.56+33.90 36.34+24.38 4.46 8.90 <0.001 level in mg/dl Control 142.61+12.73 103.57+10.55 39.04+13.94 25.48 1.613 >0.1 2. Post meal blood Treated 221.46+ 42.40 180.4+25.53 41.06+ 48.66 8.89 4.91 <0.001 sugar level in mg/dl Control 236.02+52.91 164.11+ 16.40 71.91+ 52.95 9.68 7.42 <0.001 Table 7: Showing Total Effect of Therapy on 60 Patients of Sthula Madhumeha S.N. Total Effect of Therapy Group of Treatment Total No. of Patients Percentage 1 Cured Treated 00 00 Control 00 00 2 Markedly improved Treated 26 86.66% Control 24 80% 3 Improved Treated 04 13.33% Control 06 20% 4 Unchanged Treated 00 00 Control 00 00 5 LAMA Treated 00 00 Control 00 00 International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 272

4. Discussion The effect of Therapy was assessed mainly on clinical features. Randomly selected 60 patients of Sthula Madhumeha (~Obesity induced DM) including both groups analyzed statistically in the following manner. 4.1. Effect of Therapy Observing the Table (1) to (5) it was conclude that Kadaradi compound drug has very positive result on Medadhatu. Statistical analysis also showed that significant reduction in weight, hip to waist ratio. (Table 3) Total cholesterol, Low density lipoprotein and Serum Triglycerides were also reduced significantly (Table 4) 4.2. Total Effect of Therapy Table (7) show more patients markedly improved in treated group than control group. While more patients improved in control group than treated group. 5. Conclusion [A]. The Statistical study shows reduction in Meda Dhatu, which indicated important role in the manifestation of Sthula Madhumeha (~Obesity induced DM). [B]. Significant reduction shows in Weight, Hip-Waist ratio and circumference of Abdomen, Hip and Waist. [C]. Reduction found in total cholesterol, Serum Triglycerides, Low density lipoproteins were also observed. [D]. Maximum Kapha Vridhi Lakshanas reduced while positive effect on Rasa Dushti, Majja Dusti, and Meda Dhatu dusti also observed. [E]. More patients markedly improved in treated group rather than control group, which indicates efficacy of Kadaradi compound drugs in Sthula Madhumeha (~Obesity induced DM). References [1] Kumar and Clark, M., 1998: Clinical Medicine. 4th Edition, W.B. Saunders, An imprint of Harcourt Brace and Company Ltd. [2] Harrison, 2001: Principals of Internal Medicine. 15th Edition, Vol. 2. McGraw Hill, Medical Publishing Division. [3] Charaka Samhita, 1991: Commentary by Brahmanand Tripathi, Reprint Edition, Vol. 1 & 2, Chaukhambha Surbharti Prakshan, Varanasi. [4] Chakradatta of Shri Cakrapanidatta with Padarthabodhini Hindi Commentary by Vaidya Ravidatta Shastri, Reprint 2000, Chaukhambha Surbharti Prakshan, Varanasi. [5] Charaka Samhita, 2004: 1st Edition by Agnivesa Revised by Carka and Drdhabala with the Ayurveda Dipika Commentary Cakrapanidatta edited by Vaidya Jadavaji Trikam Ji. Acharya, Chaukhambha Orientalia, Delhi. Verse no.6/13; 14. International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 273

[6] Tripathi, K.D., 1995: Essentials on Medical Pharmacology. 3rd Edition, Jaypee Brothers Med. Publishers (P) Ltd, New Delhi. 234-252. [7] Davidsons, 1999: Principles and Practice of Medicine. Edited by, Christopher Haslett, Edwin R. Chilvers, John A.A. Hunter Nicholas A. Boon; Churchill Livingstone. International Journal of Advanced Ayurveda, Yoga, Unani, Siddha and Homeopathy 274